Materials and methods for detecting and/or predicting necrotizing enterocolitis in infants

Abstract

The subject invention pertains to materials and methods for diagnosing and/or predicting pathologic infant conditions. A method of the invention comprises obtaining a biological sample from an infant and analyzing the sample to detect at least one protein biomarker of necrotizing enterocolitis (NEC), wherein a patient is diagnosed with NEC or determined to have a likelihood of developing NEC following detection of the biomarker. In another method of the invention, the likelihood of a patient developing NEC is determined. In certain embodiments, treatment is administered to the patient following diagnosis of NEC or determination that the patient has a likelihood of developing NEC.

I claim: 
     
         1 . A method for diagnosing necrotizing enterocolitis (NEC) in an infant, wherein said method comprises: (a) obtaining a buccal sample from an infant patient; (b) analyzing the sample to detect at least one protein biomarker of NEC; and, based on the detection of the at least one protein biomarker, (c) diagnosing NEC in the patient. 
     
     
         2 . The method according to  claim 1 , further comprising the step of treating the NEC. 
     
     
         3 . The method according to  claim 1 , wherein the infant patient is a neonate. 
     
     
         4 . The method according to  claim 1 , wherein the infant patient is a preterm infant. 
     
     
         5 . The method according to  claim 1 , wherein detection of the at least one protein biomarker includes determining a level of the at least one protein biomarker in the sample. 
     
     
         6 . The method according to  claim 1 , wherein detection of the at least one protein marker is determined by an immunoassay. 
     
     
         7 . The method according to  claim 6 , wherein the immunoassay is an ELISA assay. 
     
     
         8 . The method according to  claim 1 , wherein the at least one protein biomarker is selected from the group consisting of: peroxiredoxin, IL-IRA, and alpha 1 anti-trypsin. 
     
     
         9 . The method according to  claim 1 , wherein the at least one protein biomarker is IL-1RA. 
     
     
         10 . The method according to  claim 1 , further comprising the step of conducting at least one further diagnostic test for NEC to confirm diagnosis of NEC in the patient. 
     
     
         11 . The method according to  claim 10 , wherein the diagnostic test for NEC is selected from the group consisting of: analysis of intestinal microbiota; analysis of urinary intestinal fatty acid binding protein (I-FABP), claudin-3, and calprotectin; white blood cell counts; platelet counts; abdominal x-rays; and blood cultures. 
     
     
         12 . A method for diagnosing and treating NEC in an infant, wherein said method comprises: (a) obtaining a buccal sample from an infant patient; (b) analyzing the sample to detect at least one protein biomarker of NEC selected from the group consisting of peroxiredoxin, IL-1 RA, and alpha 1 anti-trypsin; and, based on the detection of at least one of these protein biomarkers, (c) diagnosing NEC in the patient, and (d) treating the patient diagnosed with NEC. 
     
     
         13 . The method according to  claim 12 , wherein the infant patient is a neonate. 
     
     
         14 . The method according to  claim 12 , wherein the infant patient is a preterm infant. 
     
     
         15 . The method according to  claim 12 , wherein the at least one protein biomarker is IL-1RA. 
     
     
         16 . A method for determining an infant's likelihood of developing NEC, comprising: (a) obtaining a buccal sample from an infant patient; (b) analyzing the sample to detect at least one protein biomarker of NEC selected from the group consisting of peroxiredoxin, IL-1RA, and alpha 1 anti-trypsin; and, based on the detection of the at least one protein biomarker, (c) determining the infant's likelihood of developing NEC. 
     
     
         17 . The method according to  claim 16 , wherein the infant patient is a neonate. 
     
     
         18 . The method according to  claim 16 , wherein the infant patient is a preterm infant. 
     
     
         19 . The method according to  claim 16 , wherein the at least one protein biomarker is IL-1RA. 
     
     
         20 . The method according to  claim 16 , further comprising the step of treating the infant.